Outreach vs. Engagement: What it means and why it matters

By: Ashley Moultrie, Director, DEI & Community Engagement

As it stands, outreach remains the industry standard for patient recruitment within underrepresented communities, but why? The fruitless results of this approach have been overlooked for far too long, and it is time to change. In order to effectively continue the dialogue around diversity in clinical research, we must first acknowledge this reality. Javara’s Ashley Moultrie explains how and why engagement is the essential next step.

Outreach: The Current Status Quo

Outreach is the status quo in clinical research today; a very transactional ask by sponsors and CROs to traditionally marginalized or underserved communities. It is one-directional, an announcement, an alert. At times, perhaps almost a demand. It is not a conversation. When we deploy outreach strategies, we ultimately say: This is what I have, this is what I need from you, or this is what should be. The outcome? Put bluntly, sometimes the message lands; most times it doesn’t.

Right now, it is undeniable that outreach is a last-ditch effort. Say, for example, enrollment for a study opens in November, anticipated to close in June of the following year. As June approaches and enrollment goals remain unmet, we take a rapid-fire, all-hands-on-deck approach to recruit minority participants. Then, and only then, are we going into local communities with unparalleled urgency, to seek patient volunteers.

The undertone with which these efforts occur is not a positive one – we’re diving in with sirens blaring, bombarding communities without any context or rapport. We should not be surprised when such outreach is greeted with resistance and confusion. Who are you? Why should or would I support you?

When questions are ignored or met with demands – such as a required office visit in order to obtain more information about a trial – many individuals, understandably, respond with “No, thank you.” Such an exchange halts industry advancement in its tracks. A hard no from any patient resonates within their communities as well, leading to entire populations resistant to and unsettled with the idea of clinical research.

How Did We Get Here?

This unfortunate reality stems from our creation as an industry. Historically, and largely still to this day, clinical research tailors to a small demographic. According to the FDA’s 2015-2019 Drug Trials Snapshots Summary Report, men make up 44% of trial participants in the United States, with 78% of those individuals being white.

In 2020, The COVID-19 pandemic placed a spotlight on the major inequities plaguing the industry and the resulting impact on drug development. All of a sudden, we shifted from intentional exclusion to a very calculated, disconcerting attempt to “target” marginalized communities. Outreach, in sum, has always been an afterthought, an entirely transactional exchange, and one we rely on far too heavily.

Defining Engagement

By acknowledging the ineffective nature of outreach, we can transition effectively to understanding and implementing engagement practices instead.

Engagement is a conversation. It is the act of entering someone else’s community with an open heart and an open mind, with the intent to be of service. By engaging within the community, we provide an opportunity for bi-directional dialogue. Before we even speak about a trial or clinical research as a whole, we seek to meet individuals where they are. What do you need? What concerns you? What brings you joy? How can I support you?

It is within this context that we learn of potential ways to serve. Eventually, we land on a mention of clinical research, delivering the message in a way that aligns with the realities of that community. Conversations about services and support begin as soon as possible – and they do not stop at the close of trial enrollment. We must be consistent and reliable. After all, our goal is to support more patients through their health journeys through clinical trial access, awareness, and opportunities. If done appropriately, engagement is mutually beneficial. It is also scalable and helps build community.

Engagement in Action

An example of intentional and effective engagement efforts includes mindful selection and integration at the site level. If we have a trial looking to enroll a significant portion of African Americans, we must mindfully identify locations that best represent the identified patient population.

So, what can we do? At the most foundational level, when thinking about starting new site locations, take a survey of the local population. Consider the average income, the demographic breakdown, and the culture. When we start talking about diversity, the further outside major cities and affluent centers we go, that’s where we find the beautiful differences of people.

If we gravitate only toward the usual, “popular” sites, we run into diversity roadblocks in multiple capacities, lending to the tendency to revert back to old outreach efforts. To be clear, these locations should not be ignored or excluded, they are important in their own right. But in the context of greater diversity – both of patients and of physician investigators – these locations cannot and should not be primary.

The bias is that people want to work with people who look like them, worship like them, celebrate like them, be they sponsors, CROs, physicians, etc. We reach out to those who are familiar to us. Thus, in locations such as these, with a large dominance of white males, what results is a continuous cycle lacking diversity. How do we break the cycle? With intentionality and mindful action.

Yes, Money Matters

There is no denying, we spend a lot of dollars on a lot of things in clinical research. 10 years ago, community was not on the minds of clinical research leaders. Today, everyone is aware of the need to increase diversity across the industry. But how?

We need to put our money where our mouth is. It is vital that sponsors include dollars for community engagement in every study budget and recognize the intrinsic value of fostering community-based and non-profit partners. Specifically, as sponsors, one cannot admit that we must be engaging at the local level while failing to provide the support necessary to make that engagement happen.

Dollars and FTEs are behind all community health and engagement work. Clinical research should be no different. The idea that these professionals and programs need money backing them just like everything else is not new. As an industry, we are well aware of what must be done. But sadly, a lot of people in positions of authority appear to see community engagement as non-essential. They smile and nod, but say “well, let’s just wait and see.”

Industry Power Players

To those in leadership positions, or any other relative position of power: please listen. Listen to the people whom you have identified as your chosen leader(s) for DEI efforts. Listen, and then respond to their ask. Having recognized a need for more direct, extensive, personal leadership regarding such efforts, you placed that individual in their designated role to help guide the way. But you must allow them to do so. Whether it be working groups, or advisory councils, DEI leaders or community liaisons, I challenge you to emphasize their needs. Allow them the time, space, and resources to do what needs to be done.

And when success has been achieved, in developments both large and small, reach OUT. Reach out across the aisle to others and begin a new conversation. Share your initiatives, bring light to the most drastic needs. Explain your strategic plan for improving lives through engagement and community building. Share your commitment to change and encourage them to do the same.

What can YOU do?

While not all of us are in positions of authority or otherwise directly involved in decision-making processes, we all have a voice, and it is our responsibility to use it. First and foremost, we must make the ask. Ask for the support needed to do the work. Identify people, places, and things that you and your colleagues can do to support your local communities, and then take that information back to your leaders and organizations.

Together, we have the power to ensure that individuals, teams, organizations, and the entire industry act, but we have to ask for what we need. If you are a quiet follower, for whom shouting from the rooftops is your most terrifying nightmare, support the supporters. There is a role, a place, and responsibility fit for everyone – so long as collectively, we understand the importance of what we are doing, what we are asking for and why.

Ashley Moultrie is a seasoned professional with over 10 years of experience driving health equity through clinical research. She is responsible for leadership and oversight of Javara’s commitment to advancing diversity, equity, and inclusion practices internally, in the industry, and in the communities we serve. She works with leaders at all levels of the organization to provide strategic direction and build partnerships to advance DEI practices, increase access to clinical trials for underrepresented populations, and champion Clinical Research as a Care Option (CRAACO) for all.